MAUDE Adverse Event Report: ZIMMER DENTAL ABUT,HEX-LOCK,CONT,4.5X4.; DENTAL SCREW

Model Number	ZOA441A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint number (b)(4).
Event or Problem Description
It was reported that on (b)(6) 2019 the patient noticed mobility in the crown and it was not possible to unscrew it.Patient is waiting for the new abutment to place a new crown.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4) one abut,hex-lock,cont,4.5x4.(zoa441a) was returned.Visual inspection of the as returned product identified slight damage to the top of abutment possibly due to the removal process.No damage to the screw identified.Functional testing was performed for the returned product with an in-house stock device and threads and seats as intended.However, functional testing can not be performed on 'loosening' because the event can not be recreated on a single use item.There is also no sign of damage that would contribute to loosening.No pre-existing conditions were noted on the per.The reported device was located on tooth # 36 and was used for approximately a year.Pictures or x-ray images were not provided.Review of appropriate documentation: documents reviewed: instructions for use forative components for trabecular metal¿, tapered screw-vent, and screw-vent implant systems ifu 9664 rev 3 - 11/19 information identified: 'contraindications' 'warnings' 'breakage' dhr review was completed for the subject lot number (2019031678).It was confirmed that all operations and inspections were executed as per applicable procedure.No deviations or non-conformances, which could have caused or contributed to the reported event was noted as part of the dhr.Lot was inspected and passed all acceptance criteria by qa.Complaint history review: complaint history review was performed for the reported lot number (2019031678) for similar event and no other complaint was identified.January post market trending was reviewed and there were no actionable events or corrective actions for the reported event or device.Based on the available information, device malfunction and the reported event was non-verifiable.
Additional Manufacturer Narrative
Zimmerbiomet complaint number (b)(4).
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: ABUT,HEX-LOCK,CONT,4.5X4.
• Common Device Name: DENTAL SCREW
• Manufacturer (Section D): ZIMMER DENTAL; 4555 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 11271311
• Report Number: 0002023141-2021-00257
• Device Sequence Number: 4188638
• Product Code: NHA
• UDI-Device Identifier: 00889024020764
• UDI-Public: (01)00889024020764(17)240410(10)2019031678(241)ZOA441A
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K052600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: ZOA441A
• Device Catalogue Number: ZOA441A
• Device Lot Number: 2019031678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/09/2021; 04/12/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 02/09/2021; 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1